Reporting and Analysis Associate Director

Job Purpose and Key Responsibilities: 

The essence of the this role is to work with a high level of independence to achieve one or more of the following:

• Provide expertise and guidance to the team members in R & A activities
• Extensively support in resolving the complex tasks or time sensitive business requests
• Is a Subject Matter Expert and understands, articulates and implements best practices related to Systems Reporting & Analysis
• Expert in project management. Ability to lead project teams of various sizes and lead the project towards completion
• Plan, prepare, co-ordinate the audit/inspection programme and independently resolve audit/ inspection issues  identified for the team
• Expert in assessing the new activity/task. Performs fit-gap analysis of new process being implemented.
• Involvement in Global Projects. Developing structured approach for better performance. Ensuring efficient project management procedures are implemented to enable monitoring of projects and accurate reporting of progress
• Conduct management monitoring to ensure set quality standards are met and process or procedures are being adhered to. Identify trends or training needs based on the management monitoring results
• Identify process improvement areas in the team and develop plans to effectively improve the same
• Identifying and assessing future and current training needs
• Gain technical/non technical competencies outside of the team (when applicable)
• Accommodate additional technical/non-technical requests from various business units
• Performs other duties as assigned
• Identifying and formulating the team and technology strategy
• Setting and Executing the goals that fulfil the team and organizational objectives
• Bringing improvements that benefit the team and overall organization
• Provide a clearly-defined communication channel between GSK safety systems stakeholders/users worldwide, Regulatory Authorities, Safety teams, and IT vendors and suppliers in three key areas – systems delivery, systems validation and systems support.
• The key systems management activities are: 

• Business Analysis
• Data Analysis
• Systems Validation
• Systems Support and Maintenance

• This position ensures that the design, implementation, maintenance and support of PV systems enable GSK to efficiently, timely, accurately, and consistently report and analyze data from all relevant data sources to support the full range of PV activities, ensuring effective monitoring of the safety of our marketed products and investigational compounds.

Accountability:

Business Analysis:  Innovative and logical thinking to enable organizational change by mapping complex operational needs into robust, clear requirements; and by performing impact analysis to ensure there are no negative effects on other systems and processes. Proactively identify opportunities to improve existing systems and processes.

Data Analysis: Extracting, inspecting, cleaning, transforming and modeling raw data with the goal of highlighting useful information, suggesting conclusions and supporting decision making.

Systems Validation:  The documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. Plan, execute, report on user acceptance testing and archive test findings for diverse regulated systems.  Be able to produce evidence of systems validation to internal and external auditors.

Support:  Respond to client or end-user requests by diagnosing and resolving problems and incidents that fall within defined guidelines and/or escalating or transferring problems and incidents to other technical support teams and/or outside vendors as appropriate to ensure ongoing business operations. Knowledge and understanding of user needs when issues are raised and provision of timely and expert resolution and advice.  Support includes but is not limited to query and reporting support as well as managing helpdesk requests. Work across the organization to resolve end-user requests and incidents in a timely manner.

Complexity (this is best illustrated for this role by the behaviors needed to perform effectively):

• Leadership:  Understand how your work supports the team’s goals and the organizational priorities and applying sound judgment to all that you do.

• Decision Making:  Makes well thought-out yet efficient decisions based on pertinent facts, relevant information and good judgment.  Identifies key issues, analyses cause-effect relationships, clarifies input from different sources, and reaches appropriate decisions in a timely manner.

• Embracing Change/Innovation:  Questions the status quo. Generates new ideas.  Recognises the need for new or modified approaches and brings perspectives and approaches together, combining them in creative ways.

• Teamwork:  Works effectively with others to achieve business goals and objectives. Bridges personal, business and cultural differences to work effectively in team settings.

• Business Orientation: Understanding of the operational challenges of safety stakeholders and other customers.  Recognises issues and initiatives important to the business in order to facilitate development of business benefits cases and effective prioritisation in order to move the business forward.

• Customer Focus:  Understands their (internal and external) customer’s business.  Understands customers’ needs and works with them to help solve their problems.  Acts quickly to respond to customers’ needs.

• Communication:  Listens to others: actively attends to and conveys understanding of the comments and questions of others; listens well in a group. Speaks effectively: speaks clearly and expresses self well in groups and in one-to-one conversations.  Writing skills: conveys information clearly and effectively through both formal and information documents; reviews and edits written work constructively.  Delivers presentations effectively: prepares and delivers clear, smooth presentations; carries self well in front of a group.  Strong influencing and negotiation skills.

Responsibilities:

Role will have to ensure adherence to GSK’s and external regulators’ computer system validation guidelines for developing and maintenance of PV Systems solutions while interacting with OASIS system users (Global, Japan, Local Operating Companies, and Vendors) with specifications in one or more of the following areas:

• Expert in completing assigned reporting tasks/activities per the approved processes, including accurate documentation of the updates
• Expert in managing associate technical tasks, to facilitate simple to complex ad-hoc report requests and custom report requirements
• Expert in independently handling the trouble shooting of issues and resolve tickets with respect to Custom Reporting environment or Reporting & Analysis system
• Manage a group of direct reports who performs Reporting & Analysis activities : Development/Testing/Deployment and Maintenance
• Work with stakeholders within Systems and Safety to ensure the R&A system meets the requirements of the users and regulators
• Serves as single point of contact for any Reporting environment related business queries
• Should drive and complete projects or tasks
• Expert understanding of the Query/Reporting Environment setup and underlying procedures/systems
• Expert in writing and executing report specifications/requirements documents and UAT/Other Testing procedures as per the processes defined
• Expert in supporting help desk requests within query and reporting environments
• Expert in preparing and validating the different types of Audit line listings and periodic reports generated from the Safety Database or reporting environments
• Expert in preparing various reports as per the business requirements and evolving needs in the industry or business area
• Strong knowledge and experience in the area of regulatory inspections and internal audit requirements
• Expert in handling Reporting Environments and Infrastructure requests
• Expert in developing and publishing various models and reports as per the business requierments
• Expert in identifying the improvement areas and implementing best practices within the team or business area
• Expert in fine tuning the existing reports and analyzing/reporting environments for performance improvements
• Independently interact with relevant stakeholders/teams, to communicate any changes in the Systems or progress on projects related to Pharmacovigilance Systems and Reporting Environments
• Work with OASIS system users to organize and complete PV Systems related tasks independently
• Expert in completing the quality control activities for self and team
• Should be expert in reviewing and approving UAT/other validation or GxP sensitive documentation and reviewing of system requirements.
• Expert in handling adhoc business questions and writing complex SQL independtly
• Expert in conducting management monitoring activities
• Being audit ready. Proven ability to participate and contribute during audits and inspections and close any findings for self/team.

Competencies:

• Strong PV experience
• Proven leadership abilities including the people and project management
• Expert knowledge of clinical safety and pharmacovigilance data, or equivalent experience working to support query and reporting environments in other domains
• Logical thinking to perform independent analysis resulting in comprehensive requirement definition or problem resolution
• Good at critical thinking and solution oriented
• Expert in systems skill including: Safety database/Datamart and underlying procedures/systems
• Expert in business analysis, capable of documenting requirements based on end user input
• Thorough understanding of GxP testing and validation processes
• Expert knowledge of incident, problem, knowledge and change management processes and best practices
• Expert knowledge of the data querying and reporting tools which includes, but not limited to Cognos, Qlik, Power BI, Spotfire, etc.
• Expert knowledge of the latest reporting solutions and industry best practices to deliver on the inhouse reporting requirements efficiently and effectively
• Expert understanding of Reporting environment setup and Infratstructure/Administrative concepts, including report development, testing, deployment
• Excellent computer skills including Word, Excel, PowerPoint and Sharepoint
• Expert in coaching and influenzing team members
• Ability to work independently within tight deadlines while under pressure, while maintaining a high level of accuracy, attention to detail and integrity.
• Should be able to complete projects or tasks at varying levels in size and complexity
• Knowledge of global organization structure for interaction with stakeholders and users worldwide
• Bridges personal, business and cultural differences to work effectively in team settings
• Proficient in stakeholder management and customer focus
• Results driven with a sense of urgency that ensures timelines within personal control are met
• Demonstrates learning agility inline with the evolving needs of business
• Develops self and others

Education –

Bachelor/Master degree in an information management, business analytics, data query/reporting environments or related field with a minimum of 12-16 years of experience in the pharmaceutical industry, pharmacovigilance, or equivalent work experience.

私たちの目標 は、世界で最も革新的で、最高のパフォーマンスを実現し、信頼される企業の 1 つになることです。私たちは、私たち全員が何かユニークなものを GSK にもたらすと信じ、知識、経験、スタイルを結集させると、その影響はとてつもないものになります。患者さんと消費者に最善を尽くす意欲を育てる GSK の冒険にご参加ください。自然体で気分よく成長し続けることができる場所です。

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